NDC 53217-010

NifedicalXL XL

Nifedipine

NifedicalXL XL is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Nifedipine.

Product ID53217-010_c8bbdb77-8cb5-437b-96b7-a064ba98c84d
NDC53217-010
Product TypeHuman Prescription Drug
Proprietary NameNifedicalXL XL
Generic NameNifedipine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2000-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA075289
Labeler NameAidarex Pharmaceuticals LLC
Substance NameNIFEDIPINE
Active Ingredient Strength60 mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-010-90

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53217-010-90)
Marketing Start Date2000-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-010-60 [53217001060]

NifedicalXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-12-11
Inactivation Date2020-01-31

NDC 53217-010-90 [53217001090]

NifedicalXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-12-11
Inactivation Date2020-01-31

NDC 53217-010-30 [53217001030]

NifedicalXL XL TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075289
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-12-11
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIFEDIPINE60 mg/1

OpenFDA Data

SPL SET ID:2b62f40a-610e-4f37-8798-eaa7bf9377cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351438
  • 1812013

    • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]

    NDC Crossover Matching brand name "NifedicalXL XL" or generic name "Nifedipine"

    NDCBrand NameGeneric Name
    53217-010NifedicalXL XLNifedicalXL XL
    0228-2497NifedipineNifedipine
    0228-2530NifedipineNifedipine
    0378-0353Nifedipinenifedipine
    0378-0360Nifedipinenifedipine
    0378-0390Nifedipinenifedipine
    0378-0480Nifedipinenifedipine
    0378-0481Nifedipinenifedipine
    0378-0494Nifedipinenifedipine
    0615-5541Nifedipinenifedipine
    0615-6563Nifedipinenifedipine
    0615-7571NifedipineNifedipine
    0904-6544NifedipineNifedipine
    0904-6545NifedipineNifedipine
    0904-7080Nifedipinenifedipine
    0904-7081Nifedipinenifedipine
    0904-7082Nifedipinenifedipine
    0904-7208NifedipineNifedipine
    0904-7229NifedipineNifedipine
    10370-677NifedipineNifedipine
    10370-678NifedipineNifedipine
    10370-679NifedipineNifedipine
    21695-807nifedipinenifedipine
    21695-908nifedipinenifedipine
    21695-909NifedipineNifedipine
    23155-194NifedipineNifedipine
    23155-195NifedipineNifedipine
    0069-2600Procardianifedipine
    0069-2650Procardianifedipine
    0069-2660Procardianifedipine
    0069-2670Procardianifedipine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.